MabThera use to double with first line indication
pharmafile | August 11, 2004 | News story | |Â Â Â
Roche's cancer drug MabThera (rituximab) has received European approval for a new indication – the first line treatment of indolent non-Hodgkin's lymphoma (NHL) in combination with standard chemotherapy.
The company expects the frontline use of MabThera to double the number of patients eligible for treatment with the drug, already its biggest selling brand. In the first half of this year sales grew 27% to CHF1.6 billion contributing to an overall 28% sales growth of Roche's oncology division.
"This approval is excellent news for the many indolent NHL patients suffering from this potentially fatal disease," said William M. Burns, head of Roche's Pharmaceuticals division. "MabThera in combination with chemotherapy is a vital treatment option, and making it available to patients across Europe underlines its position as the standard of care in indolent NHL."
The new indication approval was based on a 321-patient phase III study which showed MabThera (Rituxan in the US) in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy to be significantly superior to CVP chemotherapy alone.
In particular, time to treatment failure was prolonged by more than one and a half years (26 months versus seven months); patients were disease-free for almost twice as long (27 months versus 15 months); more patients responded to the combination treatment (81% versus 57%); and the complete response rate quadrupled to 41% from 10%.
"This approval for MabThera marks a major advance in the treatment of indolent NHL," said Kapil Dhingra, vice president Roche Oncology. "By every criterion of effectiveness, whether time to progression, disease-free survival or duration of response, patients who received MabThera in addition to chemotherapy had a superior outcome as compared to those receiving conventional chemotherapy only. This is the first time that the addition of a well tolerated biologic agent to chemotherapy has led to such a significant clinical benefit in this condition."
The indolent type of NHL affects about 675,000 people worldwide (45% of the total) and is a slow developing but serious cancer of the lymphatic system, with patients prone to relapse after treatment.
MabThera/Rituxan monotherapy was approved for the treatment of relapsed or refractory indolent NHL in 1998 and in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy for treatment of aggressive NHL in 2002.
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